FDA Grants Exemption to Connected Trading Partners - FDA.gov

• If your company needs a California Designated Representative - Wholesaler, or a California Designated Representative - 3PL, they'll need Board-approved training to apply for their Designated Representative license application. 
• Board-approved California Designated Representative courses: - Wholesaler Training Course - 3PL Training Course - Reverse Distributor Training Course 

Updated September 1, 2026

You might also like:

Exemptions under the Drug Supply Chain Security Act - FDA.gov:

https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/exemptions-under-drug-supply-chain-security-act

---  the original post follows below  ---

The FDA has issued another DSCSA exemption, and posted a summary of it, on their Waivers and Exemptions Beyond the Stabilization Period webpage. 

In a nutshell, in the October 9, 2024 exemption, the exemptions apply to any partners who have completed or made documented compliance efforts but still face data exchange challenges. The FDA said it is granting additional time to avoid supply chain disruptions that may impact patients’ access to needed medications.

Go to the Waivers and Exemptions Beyond the Stabilization Period webpage:  https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/waivers-and-exemptions-beyond-stabilization-period

Return Home:  The Designated Representative and Exemptee Blog

For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training  
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

The FDA On DSCSA Deadlines For Small Pharmacies

The FDA is offering exemptions to the DSCSA deadlines for small dispensers (pharmacies).

This probably doesn't come as a surprise, yet this could have some ramifications for other trading partners.

Read more about:  

FDA Grants Exemptions to Small Dispensers - Waivers and Exemptions Beyond the Stabilization Period - FDA.gov

Return Home:  The Designated Representative and Exemptee Blog

- - -

For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training  
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

DSCSA Readiness - A Long Way To Go

• Board-approved training programs for California Designated Representative license applicants:
• Designated Representative - Wholesaler
• Designated Representative - 3PL
• Designated Representative - Reverse Distributor

Updated July 31, 2026

Companies Are Not Ready

The end to end pharmaceutical supply chain still isn't ready for DSCSA implementation.

Some articles are warning that the November 2023 date will be a challenge:

• Pharmaceutical supply chains raise data concerns as traceability law nears final step - Supply Chain Dive

Return Home:  The Designated Representative and Exemptee Blog

- - -

For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training  
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

FDA Issues Two DSCSA Draft Guidances

• Board-approved California Designated Representative online training programs by SkillsPlus International Inc. | Training courses for wholesalers, 3PL, and reverse distributors.

The FDA issued 2 DSCSA draft guidances:

Date Published	Type	Title
7/05/2022	Draft Guidance	Identifying Trading Partners Under the Drug Supply Chain Security Act
7/05/2022	Draft Guidance	DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs Guidance for Industry

View the full list of Drug Supply Chain Security Act Law and Policies - FDA.gov

Return Home:  The Designated Representative and Exemptee Blog

- - - 

For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training  
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

The Clock is Ticking: Comments to Proposed Federal Rules For Wholesalers and 3PLs are Due June 6th and Here’s What We Think - JDSupra

• California Board-approved California Designated Representative online training courses for: Wholesalers | 3PL (third-party logistics providers) | Reverse Distributors

Updated May 27, 2022:

The FDA has extended the due date for comments. 

"The Agency has received a request for a 90-day extension of the comment period for the proposed rule. The request conveyed concern that the current 120-day comment period, which ends on June 6, 2022, does not allow sufficient time to develop a meaningful or thoughtful response to the proposed rule.

FDA has considered the request and is extending the comment period for the proposed rule for 90 days, until September 6, 2022. The Agency believes that a 90-day extension allows adequate time for interested persons to submit comments."  

Source: National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers; Extension of Comment Period - SUPPLEMENTARY INFORMATION dated May 17, 2022 - Federal Register

---  the original post follows below  ---

According to the article:

"On February 4, 2022, the FDA released its long-awaited proposed national standards for the licensure of third party logistics providers (3PLs) and wholesale drug distributors. The draft rules were years over-due and the delay increased the variation across wholesale and 3PL licensure that the federal Drug Supply Chain Security Act (DSCSA) intended to resolve. The proposed rules create more questions than answers and will likely require significant time and litigation before the rules are finalized." ...

"Here are some of the highlights we saw and questions we have about gaps or challenges in the proposed rules." ...

Read the full source article: The Clock is Ticking: Comments to Proposed Federal Rules For Wholesalers and 3PLs are Due June 6th and Here’s What We Think - JDSupra

Return Home:  The Designated Representative and Exemptee Blog

- - -

California Board-approved California Designated Representative online training courses for:

     Wholesalers | 3PL (third-party logistics providers) | Reverse Distributors

For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training  
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

New DSCSA Related Guidance Docs

• Buy now! Board-Approved California Designated Representative training courses, for:
          Wholesalers | 3PL | Reverse Distributors 

According to this FDA In Brief quote by Donald D. Ashley, J.D., Director of the Office of Compliance for FDA's Center for Drug Evaluation and Research:

"Ensuring the quality of prescription drugs and safeguarding the integrity of pharmaceutical distribution are crucial roles the FDA plays in protecting the health of the American public. Illegitimate and unsafe products must be kept out of the U.S. drug supply chain.

Since 2013, when the FDA began phasing in new requirements added by the Drug Supply Chain Security Act (DSCSA), we have helped create a supply chain that is better at preventing and detecting the introduction of illegitimate products. The new requirements can also enable stakeholders and the FDA to respond rapidly when such products are found.

To help our stakeholders understand these requirements, we are issuing guidance documents intended to assist trading partners in complying with the law and achieving a safer, more secure and more trusted drug supply chain. We are also soliciting feedback for further improving the way our drug supply chain operates within the DSCSA framework. We view these guidance recommendations as an important part of implementing the robust enhanced system envisioned under DSCSA.

We look forward to continuing open conversations on DSCSA-related issues and providing future guidance to stakeholders as part of our efforts to protect American patients and the drug supply chain we all rely on."

Read more and see the links to the four (4) newly added guidance documents: 
FDA In Brief: FDA provides new guidance to further enhance the security of prescription drugs in the U.S. supply chain - FDA.gov

Return Home:  The Designated Representative and Exemptee Blog

- - -

For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training  
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

Saleable Returns Verification

• California Board of Pharmacy Designated Representative Training. Board-approved. Taught by SkillsPlus International Inc. for reverse distributors, wholesalers, 3PL. If you are applying for a California Designated Representative license, then you’re also going to need to include proof of required training (specifically, a training affidavit) in your license application packet. Earn a training affidavit (accepted by the Board) by taking any one of our courses.

Updated September 14, 2026

The original post didn't age well.

You might also like:

Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product—Compliance Policies:

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/wholesale-distributor-verification-requirement-saleable-returned-drug-product-and-dispenser-0

---  the original post follows below  ---

Read the full source article: Saleable Returns Verification Delayed to 2023 - Healthcare Packaging

According to the article:

"Additional three-year delay: FDA guidance says distributors will not be required to verify the product identifier of returned drugs before resale until Nov. 27, 2023.   ...

With the 2020 enforcement date approaching in November, FDA has announced an additional three-year delay, noting, “FDA does not intend to take action against wholesale distributors who do not, prior to November 27, 2023, verify the product identifier prior to further distributing returned product as required under the DSCSA."

View the FDA guidance document:  Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product—Compliance Policies - FDA.gov

Return Home:  The Designated Representative and Exemptee Blog

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California Board of Pharmacy Designated Representative Training. Board-approved. Taught by SkillsPlus International Inc. for reverse distributors, wholesalers, 3PL. If you are applying for a California Designated Representative license, then you’re also going to need to include proof of required training (specifically, a training affidavit) in your license application packet. Earn a training affidavit (accepted by the Board) by taking any one of our courses.

For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training  
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

Speed-date with the DSCSA pilot project sponsors - Pharmaceutical Commerce

• California Board of Pharmacy Designated Representative Training Courses (wholesaler, 3PL) - presented by SkillsPlus Intl Inc.  - -  If you are applying for a California Designated Representative license, then you’re also going to need to include proof of required training (specifically, a training affidavit) in your license application packet. Earn a training affidavit by taking any one of our Board-approved California Designated Representative training courses.

Read the full source article:  Speed-date with the DSCSA pilot project sponsors - Pharmaceutical Commerce

According to the article:

" ... organizations conducting pilot projects addressing the Drug Supply Chain Security Act (DSCSA) filed their reports with FDA.  ...  

Now, the Partnership for DSCSA Governance (PDG)—the creation of which, strangely, was one of the pilot projects—is holding a webinar on July 23-24 for the sponsors to present their findings. The webinar will be somewhat like speed dating: each presentation (18 of the 20 have signed on) will have an 18-minute slot.  ... 

Registration for the webinar is accessible at: https://info.leavittpartners.com/dscsa-pilot-program-round-robin "

Return Home:  The Designated Representative and Exemptee Blog

-----------

California Board of Pharmacy Designated Representative Training Courses (wholesaler, 3PL) - presented by SkillsPlus Intl Inc.  - -  If you are applying for a California Designated Representative license, then you’re also going to need to include proof of required training (specifically, a training affidavit) in your license application packet. Earn a training affidavit by taking any one of our Board-approved California Designated Representative training courses.

For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training - New!
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

DSCSA Exemption And Exclusion For COVID-19 | FDA Guidance

• California Designated Representative Training Programs - Board-Approved - For wholesalers, 3PL, reverse distributors - Earns a training affidavit

Open the complete guidance:  Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act During the COVID-19 Public Health Emergency - FDA Guidance (PDF)

According to the guidance document:

"Due to the COVID-19 pandemic, FDA has been monitoring requests related to provisions of the Drug Supply Chain Security Act (DSCSA) because the provisions may affect the prescription drug supply chain during the COVID-19 outbreak. FDA is issuing this guidance to clarify the scope of the public health emergency exemption and exclusion under the DSCSA for the duration of the public health emergency declared by the Secretary of Health and Human Services (HHS)" . . .

Return Home:  The Designated Representative and Exemptee Blog

-------------

California Designated Representative Training Programs - Board-Approved - For wholesalers, 3PL, reverse distributors - Earns a training affidavit

For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training  
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

The industry-wide governance body for DSCSA compliance comes to life - Pharmaceutical Commerce

• California Designated Representative online training courses for wholesalers, 3PL, reverse distributors. Earns a training affidavit accepted by the California State Board of Pharmacy.

Read the full article:  The industry-wide governance body for DSCSA compliance comes to life - Pharmaceutical Commerce

According to the article:

"As has been known for years, establishing a successful implementation of the Drug Supply Chain Security Act (DSCSA) will require close coordination among manufacturers, wholesaler-distributors, pharmacies and health systems (even, conceivably, individual doctor’s offices)—a tall order. Yet there has been no reliable mechanism for accomplishing this coordination—apart from banging on FDA’s door—to date. That is changing now with the establishment of the Partnership for DSCSA Governance, Inc. (PDG), an independent, nonprofit, “sector neutral” (as it characterizes itself) group to work out the steps toward DSCSA compliance by the law’s 2023 deadline.

Return Home:  The Designated Representative and Exemptee Blog

---------------------

• California Designated Representative online training courses for wholesalers, 3PL, reverse distributors. Earns a training affidavit accepted by the California State Board of Pharmacy.

For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training  
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

The FDA Considers PI a Closed Issue – So Why the Confusion? - LSPediA

• Board-approved California Designated Representative online training courses for wholesalers, 3PL, reverse distributors. Earns a training affidavit.

Updated August 19, 2026

You might also like:

Product Identifiers under the Drug Supply Chain Security Act - Questions and Answers - 

Guidance for Industry - FDA.gov:

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/product-identifiers-under-drug-supply-chain-security-act-questions-and-answers

---  the original post follows below  ---

Read the full article:  The FDA Considers PI a Closed Issue – So Why the Confusion? - LSPediA

I hope this doesn't come as a surprise.

According to the article:

"It’s been 14 months since the FDA advised manufacturers, wholesalers, and repackagers on Product Identifier (PI) requirements. You’ll remember that it came as a bit of a shock to most in the industry that what they’d been doing—following the GS1 standard of a GTIN with an embedded 10-digit National Drug Code (NDC) number, plus the serial number, lot number, and expiration date—was insufficient for PI purposes.

The FDA’s draft guidance said that was close to what they wanted, but not close enough. They dismissed the GTIN and confirmed the requirement of using the NDC number as one of the building blocks of a PI. The exact language was found in the answers to questions 4 and 5 of the guidance."

Return Home:  The Designated Representative and Exemptee Blog

----------------

Board-approved California Designated Representative online training courses for wholesalers, 3PL, reverse distributors. Earns a training affidavit.

For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training  
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

GS1 Lightweight Messaging Standard

• The largest selection of Board-approved California Designated Representative online training programs. 3 distinct courses for wholesalers, 3PL, reverse distributors. Earns a training affidavit.

Open the full guideline document:   GS1 Healthcare US - Implementation Guideline - Applying the GS1 Lightweight Messaging Standard for DSCSA Verification of Returned Product Identifiers (PDF)

According to the guideline document:

"In preparation, pharmaceutical supply chain stakeholders collaborated with GS1® and GS1 US® to develop a verification messaging standard to enable system interoperability and prevent the proliferation of multiple messaging formats. In addition, the GS1 Messaging Standard Workgroup collaborated with the Healthcare Distribution Alliance (HDA) Verification Routing Services (VRS) Taskforce. These efforts produced the GS1 Lightweight Messaging Standard for Verification of Product Identifiers.

The GS1 Lightweight Messaging Standard was designed to support requests and responses for verification of product identifiers for serialized pharmaceutical products. It is intended to provide a simple, standardized lightweight messaging framework for asking verification questions and receiving actionable information. Designed to support Verification Routing Services (VRS) systems for DSCSA verification, the messaging standard defines a verification request message and a corresponding response message."

Return Home:  The Designated Representative and Exemptee Blog

--------------------

The largest selection of Board-approved California Designated Representative online training programs. 3 distinct courses for wholesalers, 3PL, reverse distributors. Earns a training affidavit.

For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training  
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

HHS Announces New Action Plan to Lay Foundation for Safe Importation of Certain Prescription Drugs

• California Designated Representative Online Training Classes. Largest selection, 3 distinct Board-approved courses. Earns a Board-accepted training affidavit. For: drug/device wholesalers, 3PL, reverse distributors.

Read the full news release:  HHS Announces New Action Plan to Lay Foundation for Safe Importation of Certain Prescription Drugs - HHS.gov

It's been difficult to put all the moving pieces together in a coherent manner, regarding the HHS, state-based drug importation efforts, and the DSCSA.

Here are some more pieces of the puzzle.

According to the HHS news release:

"The U.S. Department of Health and Human Services (HHS) announced today that HHS and the U.S. Food and Drug Administration (FDA) are publishing a Safe Importation Action Plan - PDF* that outlines two potential pathways that would lay the foundation for the safe importation of certain drugs originally intended for foreign markets."

But there are 4 major questions according to this article:  HHS and FDA's drug importation action plan - FierceHealthcare:

1. Will Canada play ball?
2. Will states want to play ball?
3. How will safety issues be addressed?
4. Will congressional Republicans interfere?

Return Home:  The Designated Representative and Exemptee Blog

---------------

California Designated Representative Online Training Classes. Largest selection, 3 distinct Board-approved courses. Earns a Board-accepted training affidavit. For: drug/device wholesalers, 3PL, reverse distributors.

For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training - New!
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

Can Trump/Azar/Sharpless Eliminate Parts of the DSCSA to Enable Importation? - RxTrace

• California Designated Representative Online Training Classes. Largest selection of Board-approved courses for: wholesalers, 3PL, reverse distributors. Earns a training affidavit accepted by the Board.

Read the full article:  Can Trump/Azar/Sharpless Eliminate Parts of the DSCSA to Enable Importation? - RxTrace.com

According to Dirk Rodgers:

"Can President Trump, HHS Secretary Azar and Acting FDA Commissioner Sharpless eliminate/adjust/reinterpret any part of the Drug Supply Chain Security Act (DSCSA) to allow Florida, Colorado, Vermont, Maine or any other US state or territory to import drugs from foreign markets?  Let’s take a closer look at what’s been going on recently with the idea of importing drugs from other markets in an attempt to help American citizens buy them at a lower cost."

His analysis of the situation is a worthy read.

You might also be interested in his book, "The Drug Supply Chain Security Act Explained: Second Edition, Plus Explanations Of Key FDA DSCSA Guidances 2nd Edition:"




Return Home:  The Designated Representative and Exemptee Blog

--------------------

California Designated Representative Online Training Classes. Largest selection of Board-approved courses for: wholesalers, 3PL, reverse distributors. Earns a training affidavit accepted by the Board.

For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training - New!
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

Our STAT Op-Ed: Drug Importation Can’t Coexist with U.S. Track-and-Trace Law - DrugChannels.net

• California Designated Representative Training Courses (for wholesaler, 3PL, reverse distributor). Largest selection of Board-approved California Designated Representative online training courses. Earns a training affidavit accepted by the California State Board of Pharmacy.

Read the full text of the Op-Ed:  Our STAT Op-Ed: Drug Importation Can’t Coexist with U.S. Track-and-Trace Law - DrugChannels.net

From the Op-Ed:

"As we see it, there is no legal or operational way of transforming a drug packaged for a foreign market into a drug that meets the U.S. requirements of our in-progress track-and-trace system. What’s more, there is no way to alter the law to enable importation without undermining the law’s purpose and value.  ... 

Importation laws undermine the country’s progress in building a modern technology infrastructure to track and trace prescription drugs. Making exceptions to the in-progress track-and-trace system would ignore the many instances of drug diversion and counterfeiting that led to the creation and passage of the law in 2013."

The Op-Ed covers the following areas:

• State drug importation laws undermine the process that keeps our supply chain safe
• Why the U.S. is building a track-and-trace system 
• How track-and-trace works 
• Importation undermines the track-and-trace system
• Importation enables counterfeits 
• Forgetting the lessons 

Return Home:  The Designated Representative and Exemptee Blog

--------------

California Designated Representative Training Courses (for wholesaler, 3PL, reverse distributor). Largest selection of Board-approved California Designated Representative online training courses. Earns a training affidavit accepted by the California State Board of Pharmacy.

For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training - New!
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

Supply chain group sets out model for DSCSA governance - SecuringIndustry.com

• California Designated Representative Training Courses (for wholesalers, or 3PLs) - Approved by the California State Board of Pharmacy
• Buy California Designated Representative training now:
     Wholesaler Course | 3PL Course

Updated June 12, 2026

You can still learn about the PDSA here:

PDSA Online:
https://pdsaonline.org/

---   the original post follows below  ---

Read the full article:  Supply chain group sets out model for DSCSA governance - SecuringIndustry.com

"A consortium of pharmaceutical supply chain partners in the US has come up with a proposed system of governance for data generated in a traceability scheme due to come into effect in 2023." 

"Now, the Pharmaceutical Distribution Security Alliance (PDSA) – a group which includes manufacturers, distributors, dispensers and third-party logistics (3PL) companies – has kicked off the development of its own suggested governance framework that it hopes could serve as a model for discussions going forward."

Return Home:  The Designated Representative and Exemptee Blog

---------------

California Designated Representative Training Courses (for wholesalers, or 3PLs) - Approved by the California State Board of Pharmacy

For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training  
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

SAP blockchain service helps fight counterfeit drugs - TechTarget

• California Designated Representative Training Courses (approved by the California State Board of Pharmacy) - courses for wholesalers or third-party logistics providers (3PL)  Buy a course now, for: Wholesalers | 3PL | Reverse Distributors

Updated June 12, 2026

The original link broke.

You might also be interested in:

• An Easy Path to DSCSA Interoperability: LSPediA SAP Qualified Network Connections - LSPediA

---  the original post follows below  ---

Read the full article:  SAP blockchain service helps fight counterfeit drugs - TechTarget

"SAP is working to combat counterfeit drugs. The company has released a blockchain offering that is aimed at authenticating drugs in the supply chain. 

The SAP blockchain application for the pharmaceutical industry is designed to ensure that any drugs returned to a wholesaler from hospitals and pharmacies are validated before they are resold, according to SAP. The blockchain was developed in the SAP Information Collaboration Hub for Life Sciences, a public cloud network involving several large pharmaceutical wholesalers and manufacturers, which SAP launched in November 2017."

It's getting competitive.  Looks like a lot of companies are trying to offer a DSCSA blockchain solution.

Return Home:  The Designated Representative and Exemptee Blog

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California Designated Representative Training Courses (approved by the California State Board of Pharmacy) - courses for wholesalers or third-party logistics providers (3PL)

For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training  
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

TraceLink proposes blockchain system for DSCSA pilot - SecuringIndustry.com

• California Designated Representative Training Courses (approved by the California State Board of Pharmacy) - for wholesalers or third-party logistics providers (3PL)

Read the full article:  TraceLink proposes blockchain system for DSCSA pilot - SecuringIndustry.com

"TraceLink says that its offering – called Trace Histories – is built on its digital supply network which is already widely used in the pharma supply chain. Adding blockchain means that it can now offer a system that is “designed specifically to help pharmaceutical manufacturers, wholesale distributors, pharmacies, and hospitals securely exchange information and satisfy the 2023 DSCSA requirement.”"

Return Home:  The Designated Representative and Exemptee Blog

-----------------

California Designated Representative Training Courses (approved by the California State Board of Pharmacy) - for wholesalers, third-party logistics providers (3PL), or reverse distributors

For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training  
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

Real World Product Serialization: Report from the Warehouse - LSPedia

• California Designated Representative Training Courses (approved by the California State Board of Pharmacy) - for wholesalers, 3PL, or reverse distributors
• Register to take a course now, for:
       Wholesalers | 3PL | Reverse Distributors

Updated April 23, 2024

The original link broke.

You might also be interested in:  LSPedia

---  the original post follows below  ---

Read the full article:  Real World Product Serialization: Report from the Warehouse - LSPedia

"Even though manufacturers have invested lots of time and money into DSCSA serialization compliance, the LSPediA team found that many products still won’t scan up to standards."

The article points out that serialization efforts are making slow progress, and implemented barcodes can contain errors or fail scans.

Return Home:  The Designated Representative and Exemptee Blog

-----------------

California Designated Representative Training Courses (approved by the California State Board of Pharmacy) - for wholesalers

Return Home:  The Designated Representative and Exemptee Blog

For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training  
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

FDA Issues Warning Letter To McKesson For DSCSA Violations

• California Designated Representative Training Course for Wholesalers (approved by the California State Board of Pharmacy) - earns a Board-acceptable training affidavit
• Buy a course now for: wholesalers | 3PL | reverse distributors

Updated June 20, 2025

The original link to the article broke.

---  the original post follows below  ---

Read the full article:  First Warning Letter Issued Under DSCSA - FDA sends McKesson a warning, highlighting issues with illegitimate product notification, quarantining and record-keeping - Healthcare Packaging

"According to the letter to McKesson, “The verification requirements at issue include those that apply to wholesale distributors when they determine or are notified that a product is suspect or illegitimate.”  . . . 

The letter highlights two other examples in which the firm did not demonstrate proper quarantining of suspect product or provide records to show that requirements were met in identifying illegitimate product or subsequent requirements."

Read the FDA warning letter:  McKesson Corporation Headquarters 2/7/19 - FDA Warning Letter

Return Home:  The Designated Representative and Exemptee Blog

--------------

California Designated Representative Training Courses (approved by the California State Board of Pharmacy) - courses for wholesalers, 3PL, reverse distributors

Return Home:  The Designated Representative and Exemptee Blog

For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training  
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute